SINUS WASH- sodium bicarbonate, sodium chloride powder, for solution

Sinus Wash by

Drug Labeling and Warnings

Sinus Wash by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Ascent Consumer Products Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

Purpose

Nasal wash

INDICATIONS & USAGE

Uses

Temporarily relieves symptoms associated with sinusitis, cold, flu or allergies

-Sneezing

-Nasal Stuffiness

-Runny Nose

-Post nasal drip

Removes inhaled irritants (dust, pollen)

Helps to loosen thick mucous

Moistens nasal passages

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

WARNINGS

Warnings

Stop use and ask a doctor if washing is uncomfortable or symptoms are not releived

DOSAGE & ADMINISTRATION

Directions

Adults and children 4 years and over: use 1-2 packets per 8 oz container every 2 hours as needed

Children under 4 years: consult a physician

Consult Instructions for Use inside box for proper use

WHEN USING

When using this product:

-Use by only one person

-Wash with soap and water after each use

-Top rack of dishwasher safe

-Do not heat in microwave

INSTRUCTIONS FOR USE

Instructions for Use:

Directions: Read through entire section before using for the first time.

1. Empty the contents of one Saline Sinus Wash packet into the Saline Sinus Wash Neti Pot. First-time users should start with 1/2 packet of the dry ingredients. As you become

more accustomed to the system, work up to using 1 full packet. Additional packets may be purchased from your nearest pharmacy.

2. Fill the pot halfway or to the middle of the indentation with proper water. This makes 1/2 cup (4 oz) solution.

3. Stir thoroughly until dry ingredients have completely dissolved.

4. Proper head position allows solution to run through the nose by gravity.

-Lean over the sink so that the right nostril is directly above the left. The forehead should remain higher than the chin. Raise the handle of the pot so that the solution enters the right nostril. In a few

moments, the solution will begin to drain out of the left nostril into the sink. Do not inhale or "snort" solution into the nose - breathe through your mouth.

5. When the pot is empty, exhale through both nostrils to clear them of excess mucous and solution. Gently blow your nose into a tissue.

6. Repeat the procedure on the other side.

7. Thoroughly rinse the pot after each use with water that has been distilled, sterilized, filtered or previously boiled and leave the pot to air dry thoroughly. The Sinus Wash Neti pot is top-rack

dishwasher safe.

ACTIVE INGREDIENT

Active Ingredients

(in each packet)

Sodium Bicarbonate USP 700 mg

Sodium Chloride USP 2300 mg

INACTIVE INGREDIENT

Inactive Ingredients

None

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SINUS WASH 
sodium bicarbonate, sodium chloride powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-504
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20)	SODIUM BICARBONATE	2300 mg
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CHLORIDE	700 mg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-504-30	100 in 1 CARTON	04/01/2013
1		1 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/01/2013

Labeler - CVS Pharmacy (062312574)

Establishment
Name	Address	ID/FEI	Business Operations
Ascent Consumer Products Inc		078396381	manufacture(59779-504)